Brainlab RT/RS Installation manual

RT / RS
STEREOTACTIC
HARDWARE
Hardware User Guide
Revision 4.9
Copyright 2016, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
GENERAL INFORMATION...................................................................................................7
Contact Data and Legal Information......................................................................................................7
Contact Data................................................................................................................................................7
Legal Information.........................................................................................................................................8
Symbols .....................................................................................................................................................10
Symbols Used in This Guide......................................................................................................................10
Hardware Symbols.....................................................................................................................................11
Intended Use.............................................................................................................................................12
Compatibility with Medical Devices.....................................................................................................13
Brainlab Medical Devices...........................................................................................................................13
Non-Brainlab Medical Devices ...................................................................................................................16
Training & Documentation.....................................................................................................................20
Training......................................................................................................................................................20
Documentation...........................................................................................................................................21
HARDWARE OVERVIEW....................................................................................................23
Brainlab Couchmount.............................................................................................................................23
Preparing and Handling Couchmounts.......................................................................................................23
Siemens ZXT, Elekta/Philips RAM, and Varian ETR Couch Tops...............................................................26
Siemens ZXT Carbon Fiber Couch Top......................................................................................................27
Varian Exact and Siemens TT-S Couch Tops.............................................................................................28
Couchmount Lite........................................................................................................................................30
Couchmount Adapters............................................................................................................................31
Couchmount Adapter Types.......................................................................................................................31
Couchmount Adapters: Brainlab Headring Models.....................................................................................32
Collimator Mount......................................................................................................................................33
Overview....................................................................................................................................................33
Attaching the Collimator Mount ..................................................................................................................34
Detaching the Collimator Mount.................................................................................................................35
Collimator Mount Siemens with Coded Plug ..............................................................................................36
Third-Party Labels on the Brainlab Collimator Mount .................................................................................40
Using Conical Collimators..........................................................................................................................41
Third-Party Labels on Brainlab Collimators................................................................................................46
IMMOBILIZATION HARDWARE....................................................................................47
Stereotactic Headring .............................................................................................................................47
Overview....................................................................................................................................................47
TABLE OF CONTENTS
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 3

Stereotactic Headring Components............................................................................................................48
Attaching the Fixation Posts.......................................................................................................................51
Adjusting the Torque Wrench .....................................................................................................................52
Affixing the Stereotactic Headring to the Patient ........................................................................................54
Stereotactic Mask System......................................................................................................................57
Mask System Components ........................................................................................................................57
Molding the Mask.......................................................................................................................................60
Removing and Reattaching the Mask.........................................................................................................65
Upper Jaw Support..................................................................................................................................67
Components ..............................................................................................................................................67
Attaching the Upper Jaw Support...............................................................................................................69
IMAGING.............................................................................................................................................71
Imaging with the Headring and Mask System ...................................................................................71
Localizer Design ........................................................................................................................................71
Attaching the Localizer...............................................................................................................................73
Angio Distortion Correction Module............................................................................................................75
POSITIONING FOR TREATMENT...............................................................................77
Stereotactic Target Positioner...............................................................................................................77
Overview....................................................................................................................................................77
Attaching the Overlays and Carrier Plates..................................................................................................79
Mounting the Stereotactic Target Positioner...............................................................................................80
Positioning the System for Treatment.........................................................................................................81
Using the Stereotactic Counterweight ........................................................................................................82
Target Positioner for Leksell Headring ...............................................................................................84
Overview....................................................................................................................................................84
Attaching the Overlays and Carrier Plates..................................................................................................85
Mounting the Target Positioner for Leksell Headring ..................................................................................86
Positioning the System for Treatment.........................................................................................................87
QUALITY ASSURANCE.......................................................................................................89
Winston-Lutz Test....................................................................................................................................89
Testing with the Phantom Pointer for Brainlab Headring.............................................................................90
Testing with the Phantom Pointer for a non-Brainlab Headring...................................................................92
Film Exposure............................................................................................................................................94
CLEANING, DISINFECTION, AND STERILIZATION..................................95
Reprocessing............................................................................................................................................95
Automatic Cleaning and Disinfection..........................................................................................................95
Neutral Steam Sterilization.........................................................................................................................97
Low Temperature Plasma Sterilization (LTP)..............................................................................................98
Stereotactic Hardware.............................................................................................................................99
Overview....................................................................................................................................................99
TABLE OF CONTENTS
4 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Stereotactic Headring...............................................................................................................................100
Stereotactic Mask System........................................................................................................................102
Upper Jaw Support and Reference Plates ...............................................................................................103
CT/X-Ray Localizer, CT/X-Ray Localizer for Leksell Headring.................................................................104
Stereotactic Target Positioner, Target Positioner for Leksell Headring......................................................105
INDEX..................................................................................................................................................107
TABLE OF CONTENTS
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 5

TABLE OF CONTENTS
6 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

1 GENERAL INFORMATION
1.1 Contact Data and Legal Information
1.1.1 Contact Data
Support
If you cannot find information you need in this guide, or if you have questions or problems, contact
Brainlab support:
Region Telephone and Fax Email
United States, Canada, Central and
South America Tel: [phone]
Fax: [phone] [email protected]
Brazil Tel: [phone]
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking regions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
Expected Service Life
Brainlab provides a minimum of five years of service for system components. During this time
period, spare parts as well as field service are offered.
Feedback
Despite careful review, this manual may contain errors.
Please contact us at oncology[email protected] if you have suggestions as to how we can
improve this manual.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 7

1.1.2 Legal Information
Copyright
This user guide contains proprietary information protected by copyright. No part of this guide may
be reproduced or translated without the express written permission of Brainlab.
Brainlab Trademarks
•BrainSCAN™ is a trademark of Brainlab AG.
•iPlan®is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
•Exact™is a trademark of Varian Medical Systems, Inc.
•Microsoft®and Windows®are registered trademarks of Microsoft Corporation.
•Leksell®Coordinate Frame G is a registered trademark of Elekta AB.
•STERRAD®100S is a registered trademark of Advanced Sterilization Products.
•iBEAM®is a registered trademark of Medical Intelligence Medizintechnik GmbH.
• kVue™ and Quantum™ are trademarks of WFR-Aquaplast/Q-Fix Systems.
CE Label
• The CE label indicates that the Brainlab product complies with the essential re-
quirements of European Council Directive 93/42/EEC, the Medical Device Di-
rective (MDD).
• According to the rules established by the MDD, the Linac Hardware, Stereo-
tactic Headring and Stereotactic Mask System are Class I products.
Warranty
Warranties do not apply to products that have been damaged due to accidents, misuse,
improper re-installation, or inadequate packaging in the case of return shipments.
Warranties do not apply to product components that have been modified or replaced
without the written authorization of Brainlab.
Disposal Instructions
Only dispose of electrical and electronic equipment in accordance with statutory regu-
lations. For information regarding the WEEE (Waste Electrical and Electronic Equip-
ment) directive, visit:
www.brainlab.com/en/sustainability
The collimators contain lead and should only be disposed of in accordance with statutory
regulations.
Sales in the US
U.S. federal law restricts this device to sale by or on the order of a physician.
Contact Data and Legal Information
8 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Language Information
All Brainlab user guides are originally drafted in English.
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 9

1.2 Symbols
1.2.1 Symbols Used in This Guide
Warnings
Warnings are indicated by triangular warning symbols. They contain safety-critical
information regarding possible injury, death or other serious consequences associated
with equipment misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain safety-critical information
regarding possible problems with the device. Such problems include device malfunctions,
device failure, damage to device or damage to property.
Notes
NOTE: Notes are formatted in italic type and indicate additional useful hints.
Symbols
10 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

1.2.2 Hardware Symbols
Symbols on Hardware Components
Symbol Explanation
Class I Type B equipment according to IEC 60601-1
Attention: Consult accompanying documents.
MR Unsafe
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 11

1.3 Intended Use
Indications for Use
The stereotactic hardware supplements the Linac in applying stereotactic radiosurgery and
radiotherapy. The hardware includes a collimator system, components to fixate and position a
patient for radiotherapy or radiosurgery treatments, and means of quality assurance for
radiotherapy or radiosurgery treatments.
Careful Handling of Hardware
RT/RS Stereotactic Hardware components and accessory devices comprise precise
mechanical parts that must be handled with care. Even minor damage to any of these parts
may render the entire apparatus inoperable. Do not use RT/RS Stereotactic Hardware
components if they are in any way warped, scratched, damaged, or any of the parts are
loose. The equipment must be checked and tested for proper functionality prior to each
treatment.
RT/RS Stereotactic Hardwarecomponents and accessory devices may only be operated by
trained medical personnel.
Hardware Modification
No modification of the RT/RS Stereotactic Hardware is allowed.
Compatibility with Non-Brainlab Software
RT/RS Stereotactic Hardware components may only be used with a Brainlab treatment
planning system.
MR Compatibility
All Brainlab devices and parts mentioned in this user guide are explicitly indicated as MR
unsafe (according to ASTM F2503-05) and must not be used in any other imaging devices,
except where specifically noted. This also applies to all non-metal devices and parts.
Intended Use
12 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

1.4 Compatibility with Medical Devices
1.4.1 Brainlab Medical Devices
Background
RT/RS Stereotactic Hardware is compatible with the following Brainlab medical devices:
CT/X-Ray Localizer
Localizer Types Compatible Devices
CT/X-Ray Localizer Headring
Stereotactic Mask System
CT/X-Ray Localizer and CT/X-Ray Local-
izer for Leksell BrainSCAN, iPlan RT Dose, iPlan RT Image
Target Positioner
Target Positioner Types Compatible Devices
Stereotactic Target Positioner Headring
Stereotactic Mask System
Stereotactic Target Positioner and Target
Positioner for Leksell Headring BrainSCAN, iPlan RT Dose, iPlan RT Image
Headring
Compatible Devices
Stereotactic Target Positioner
CT/X-Ray Localizer
Couchmount Adapter Brainlab Headring
Fixation Pins Brainlab Multiuse
Couchmount Adapter Brainlab Headring (for Elekta Couch)
Fixation Pins Brainlab Multiuse
Compatible Devices
Headring
Stereotactic Mask System
Compatible Devices
Stereotactic Target Positioner
CT/X-Ray Localizer
Couchmount Adapter Brainlab Headring
Mask Set for one patient
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 13

Compatible Devices
Upper Jaw Support for Mask System
Couchmount Adapter Brainlab Headring (for Elekta Couch)
Couchmount
Compatible Devices
Couchmount Adapter Brainlab Headring
Couchmount Adapter Brainlab Headring (for Elekta Couch)
Couchmount Adapter Radionics Headring
Couchmount Adapter Leksell Headring
Couch Adapter for Imaging Couch Top
Phantom Pointer for non-Brainlab Headring
Couchmount Lite
Compatible Devices
Couchmount Adapter Brainlab Headring
Couchmount Adapter Brainlab Headring (for Elekta Couch)
Couchmount Adapter Radionics Headring
Couchmount Adapter Leksell Headring
Couch Adapter for Imaging Couch Top
Phantom Pointer for non-Brainlab Headring
Couchmount Adapter
Couchmount Adapter Types Compatible Devices
All types Couchmount
All types Couchmount Lite
Brainlab Headring, Brainlab Headring (for
Elekta Couch)*
Headring
Stereotactic Mask System
Phantom Pointer for Brainlab Headring
*For Elekta Couch with restricted isocenter clearance.
Collimator Mount
Collimator Mount Types Compatible Devices
Varian without MLC
Varian with MLC
Siemens with Coded Plug Conical Collimator
Varian without MLC Film Holder Varian without MLC
Varian with MLC Film Holder Varian with MLC
Siemens with Coded Plug Film Holder Siemens
Compatibility with Medical Devices
14 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Conical Collimator Set
Compatible Devices
Collimator Mount (all)
Phantom Pointer
Phantom Pointer Types Compatible Devices
Brainlab Headring Couchmount Adapter Brainlab Headring
Couchmount Adapter Brainlab Headring (for Elekta
Couch)
Non-Brainlab Headring Couchmount (all types)
Film Holder
Film Holder Types Compatible Devices
Varian without MLC Collimator Mount Varian without MLC
Varian with MLC Collimator Mount Varian with MLC
Siemens Collimator Mount Siemens with Coded Plug
Other Brainlab Devices
Only devices and spare parts specified by Brainlab may be used with these medical
devices. Using unauthorized devices/spare parts may adversely affect the safety and/or the
effectiveness of the medical devices and endanger the safety of the patient, user and/or
environment.
RT/RS Stereotactic Hardware system components may only be used with a Brainlab
treatment planning system.
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 15

1.4.2 Non-Brainlab Medical Devices
CT/X-Ray Localizer
Localizer Types Model Manufacturer
CT/X-Ray Localizer BRW-HR and UCHR-AP
Adapter for UCHR Headring Radionics (Integra Radionics, Inc.) Burlington, MA, USA
CT/X-Ray Localizer for Lek-
sell G-Frame Headring Elekta AB, Stockholm, Sweden
Target Positioner
Target Positioner Types Model Manufacturer
Stereotactic Target Position-
er BRW-HR and UCHR-AP Adapter for UCHR Headring Radionics (Integra Radionics, Inc.) Burlington, MA, USA
Target Positioner for Leksell
Headring G-Frame Headring Elekta AB, Stockholm, Sweden
Fixation Pins Radionics Multiuse
Compatible Devices Manufacturer
BRW-HR Radionics (Integra Radionics, Inc.) Burlington, MA,
USA
Stereotactic Mask System
Compatible Devices Manufacturer
Radionics Localizer BRW- LF Radionics (Integra Radionics, Inc.) Burlington, MA,
USA
Headring
Compatible Devices Manufacturer
Radionics Localizer BRW- LF Radionics (Integra Radionics, Inc.) Burlington, MA,
USA
Couchmount
Brainlab Couchmount
Types Compatible Couch Tops Manufacturer
Brainlab Imaging Couch
Top / Varian Exact
Couch Top Varian Exact Varian, Oncology Systems,
Palo Alto, USA
Varian IGRT Couch Top with Varian
IGRT Head End Interface, Revision 2008
or later
iBEAM Couch Top with iBEAM Couch
Adapter Medical Intelligence, Ger-
many
iBEAM evo Couch Top with iBEAM evo
Couch Adapter
Compatibility with Medical Devices
16 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Brainlab Couchmount
Types Compatible Couch Tops Manufacturer
Connexion Couch Top with Connexion
Head & Neck Module (P10105-213)
kVue IGRT Couch Top with kVue Univer-
sal Tip Extension WFR-Aquaplast/Q-Fix Sys-
tems, New Jersey, USA
Quantum Couch Top with Quantum Uni-
versal Tip Extension
CIVCO Mastercouch Stereotactic Treat-
ment Module (MC STERM), Revision
Feb. 2009 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL3015 Siemens TT-M Tab-
letop Revision Nov. 2010 or later CIVCO medical solutions,
Kalona, USA
CIVCO MTIL3010 and MTIL3005 (used
for Siemens ZXT Pedestal) Revision
Nov. 2010 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL6610 and MTIL6667 (Uni-
versal Couch Top Varian Interface) Revi-
sion Nov. 2010 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL6612 (Universal Couch Top
One Piece Varian Interface) Revision
Nov. 2010 or later
CIVCO Medical Systems,
Kalona, USA
Varian ETR Couch Top Varian ETR Varian, Oncology Systems,
Palo Alto, USA
Siemens ZXT Couch Top Siemens ZXT Siemens Medical Systems,
Inc, Oncology Care Sys-
tems, Concord, USA
AK550 IGRT Carbon Fiber Couch Top Aktina Medical, New York,
USA
Siemens ZXT Carbon
Fiber Couch Top Siemens ZXT Carbon Fiber Siemens Medical Systems,
Inc, Oncology Care Sys-
tems, Concord, USA
Siemens TT-S Couch Top Siemens TT-S
Elekta/Philips RAM Couch Top Elekta/Philips RAM Elekta AB, Stockholm,
Sweden
Couchmount Lite
Brainlab Couchmount
Lite Types Compatible Couch Tops Manufacturer
Brainlab Imaging
Couch Top / Varian Ex-
act
Couch Top Varian Exact Varian, Oncology Systems,
Palo Alto, USA
Varian IGRT Couch Top with Varian IGRT
Head End Interface, Revision 2008 or lat-
er
iBEAM Couch Top with iBEAM Couch
Adapter
Medical Intelligence, Ger-
many
iBEAM evo Couch Top with iBEAM evo
Couch Adapter
Connexion Couch Top with Connexion
Head & Neck Module (P10105-213)
kVue IGRT Couch Top with kVue Univer-
sal Tip Extension WFR-Aquaplast/Q-Fix Sys-
tems, New Jersey, USA
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 17

Brainlab Couchmount
Lite Types Compatible Couch Tops Manufacturer
Quantum Couch Top with Quantum Uni-
versal Tip Extension
CIVCO Mastercouch Stereotactic Treat-
ment Module (MC STERM), Revision
Feb. 2009 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL3015 Siemens TT-M Tab-
letop Revision Nov. 2010 or later CIVCO medical solutions,
Kalona, USA
CIVCO MTIL3010 and MTIL3005 (used
for Siemens ZXT Pedestal) Revision Nov.
2010 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL6610 and MTIL6667 (Uni-
versal Couch Top Varian Interface) Revi-
sion Nov. 2010 or later
CIVCO Medical Systems,
Kalona, USA
CIVCO MTIL6612 (Universal Couch Top
One Piece Varian Interface) Revision
Nov. 2010 or later
CIVCO Medical Systems,
Kalona, USA
Varian ETR Couch Top Varian ETR Varian, Oncology Systems,
Palo Alto, USA
Siemens ZXT Couch Top Siemens ZXT Siemens Medical Systems,
Inc, Oncology Care Sys-
tems, Concord, USA
AK550 IGRT Carbon Fiber Couch Top Aktina Medical, New York,
USA
Elekta/Philips RAM Couch Top Elekta/Philips RAM Elekta AB, Stockholm,
Sweden
Couchmount Adapter
Brainlab Couch-
mount Adapter
Types
Compatible Devi-
ces Model Manufacturer
Radionics Headring Headring
BRW-HR (and com-
patible headrings)
Radionics (Integra Radion-
ics, Inc.) Burlington, MA,
USA
Leksell Headring G-Frame Elekta AB, Stockholm, Swe-
den
Collimator Mount
Collimator Mount
Types Compatible Linac Types Manufacturer
Varian without MLC Varian without MLC (Varian Clinacs with
Type III Tray Slot)
Varian, Oncology Systems,
Palo Alto, USA
Varian with MLC
Varian with MLC (Varian Clinacs with
Type III Tray Slot)
Novalis Tx
TrueBeam
Compatibility with Medical Devices
18 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Collimator Mount
Types Compatible Linac Types Manufacturer
Siemens with Coded
Plug
• Siemens PRIMUS with 3D-MLC
(58MLC)
• Siemens PRIMUS with OPTIFOCUS
MLC (82MLC)
• Siemens ONCOR with 3D-MLC
(58MLC)
• Siemens ONCOR with OPTIFOCUS
MLC (82MLC)
• Siemens ONCOR with 160 MLC
• Siemens Artiste
NOTE: Requires LINAC Console Soft-
ware Version 12.0 or higher and R&V
System Syngo RT Therapist 4.2 or high-
er.
Siemens Medical Systems,
Inc, Oncology Care Sys-
tems, Concord, USA
Other Non-Brainlab Devices
Non-Brainlab medical devices may only be used with these medical devices if specified by
Brainlab. Using unauthorized medical devices may adversely affect the safety and/or
effectiveness of these medical devices and endanger the safety of the patient, user and/or
environment.
GENERAL INFORMATION
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 19

1.5 Training & Documentation
1.5.1 Training
Brainlab Training
In order to ensure safe and appropriate use of the system, Brainlab recommends that before
using the system for the first time, all users should participate in an extensive training program
held by a Brainlab representative.
Supervised Support
• After a sufficient number of complete procedures has been successfully simulated, and
following a rigorous quality assurance review, the system can be used in selected treatments.
• A Brainlab representative must be present at such treatments to provide medical staff with
supervision and guidance where necessary.
Training & Documentation
20 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware